Spectrophotometric Method Validation for Estimation of Paracetamol Dosage Form Using 2-Chloro-5-Methoxy Aniline
DOI:
https://doi.org/10.59675/P221Keywords:
UV Spectrophotometry, Diazo coupling reaction, Paracetamol, Validation method, 2-Chloro-5-Methoxy Aniline.Abstract
In this study, a novel spectrophotometric technique has been devised that is quick and easy to use for quantifying paracetamol (PCM.) in tablets and in its pure form. The recommended process consists of two steps: First, a 2-chloro-5-methoxy aniline (2-Cl-5-OMeAn.) reagent's primary amine group is diazotized by reacting with sodium nitrite in an acidic medium to create the corresponding diazonium salt of (2-Cl-5-OMeAn.) Secondly, the diazonium salt reacts with (PCM.) in a basic medium to form a yellow-orange-colored, stable, and water-insoluble azo dye that showed a maximum absorption at 480 nm. In this study, several variables influencing the responses were optimized. The azo dye produced using (PCM.) and (2-Cl-5-OMeAn.) as a coupling reagent follows Lambert Beer's law in the (20–140 µg.mL-1) range with a 0.9995, 1.7337 × 10+3 M-1. cm-1, and 0.123 for coefficient of correlation, a molar absorptivity and sandells' sensitivity, respectively. The method has been validated statistically, offering low detection and quantification limits, high recovery percentages (> 98%) and low relative standard deviation values. The method was successfully used to evaluate traces of paracetamol in the dosage formulation (Piodol, 500 mg/tablet, PiONEER Co.).
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